Utak Laboratories Inc

FDA Filings

This page includes the latest FDA filings for Utak Laboratories Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number2022375
FEI Number2022375
NameUTAK LABORATORIES, INC.
Owner & OperatorUTAK LABORATORIES, I
Contact Address25020 AVENUE TIBBITTS --
Valencia CA 91355 US
Official Correspondent
  • Kevin M Kopp
  • x-661-2943935-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address25020 AVENUE TIBBITTS
VALENCIA, CA 91355 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
UTAK LABORATORIES, INC.
 TESTOSTERONE LEVEL 3 TESTO 3 S F MC2024-07-25
UTAK LABORATORIES, INC.
 TESTOSTERONE LEVEL 2 TESTO 2 S F MC2024-07-25
UTAK LABORATORIES, INC.
 TESTOSTERONE LEVEL 1 TESTO 1 S F MC2024-07-25
UTAK LABORATORIES, INC.
 METHANOL PLUS 2 METH+ 2 UCD2024-07-25
UTAK LABORATORIES, INC.
 METHANOL PLUS 1 METH+ 1 UCD2024-07-25
UTAK LABORATORIES, INC.
 AED PLUS AED+ S SCH 2024-07-25
UTAK LABORATORIES, INC.
 BUPRENORPHINE PLUS LEVEL 2 V2 BUP+ 2 V2 U KP 2024-07-22
UTAK LABORATORIES, INC.
 THC PLUS THC+ V2 S WSLH2024-07-11
UTAK LABORATORIES, INC.
 NICOTINE PLUS 1200 NG/ML V3 NICO+ 1200 V3 U F UWHC2024-07-11
UTAK LABORATORIES, INC.
 NICOTINE PLUS 100 NG/ML V3 NICO+ 100 V3 U F UWHC 2024-07-11
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE PLUS LEVEL 4 DA+ 1 WB IMMUN2024-07-09
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE PLUS LEVEL 3 DA+ 3 WB IMMUN2024-07-09
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE PLUS LEVEL 2 DA+ 2 WB IMMUN2024-07-09
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE PLUS LEVEL 1 DA+ 1 WB IMMUN2024-07-09
UTAK LABORATORIES, INC.
 THIOCYANATE BLANK THIOC BLK UW2024-07-08
UTAK LABORATORIES, INC.
 THIOCYANATE 2 MG/DL THIOC 2 UW2024-07-08
UTAK LABORATORIES, INC.
 THIOC 18 UW THIOCYANATE 18 MG/DL2024-07-08
UTAK LABORATORIES, INC.
 HYDROXYBUTYRIC 250 UG/ML HYDROXYBUT 250 WB AM 2024-07-08
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE LEVEL 2 DAU 2 V2 F APS2024-07-08
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE LEVEL 1 DAU 1 V2 F APS2024-07-08
UTAK LABORATORIES, INC.
 BENZOYLECGONINE LEVEL 2 BENZOYL 2 F APTC2024-07-08
UTAK LABORATORIES, INC.
 BENZOYLECGONINE LEVEL 1 BENZOYL 1 F APTC2024-07-08
UTAK LABORATORIES, INC.
 AMINES LOW AMINES H V2 CONT2024-07-05
UTAK LABORATORIES, INC.
 AMINES HIGH AMINES H V2 CONT2024-07-05
UTAK LABORATORIES, INC.
 ANTIFUNGALS LEVEL 3 A-FUNG L3 S F MAYO2024-07-05
UTAK LABORATORIES, INC.
 METHADONE CAL SET POS-M215-2-42024-07-04
UTAK LABORATORIES, INC.
 METHAMPHETAMINE POS POS-211-2U 2024-07-04
UTAK LABORATORIES, INC.
 TRICYCLICS LEVEL 2 V4 TCA L2 V4 S MAYO 2024-07-03
UTAK LABORATORIES, INC.
 OPIATES PLUS MIX OPI+ MIX ET2024-07-03
UTAK LABORATORIES, INC.
 BENZODIAZEPINES BENZO U WVHS 2024-07-01
UTAK LABORATORIES, INC.
 TOX II_10 24 TOX II_10 242024-06-28
UTAK LABORATORIES, INC.
 TOX II_09 24 TOX II_09 242024-06-28
UTAK LABORATORIES, INC.
 TOX II_08 24 TOX II_08 242024-06-28
UTAK LABORATORIES, INC.
 TOX II_07 24 TOX II_07 242024-06-28
UTAK LABORATORIES, INC.
 TOX II_06 24 TOX II_06 242024-06-28
UTAK LABORATORIES, INC.
 ETOH II_10 24 ETOH II_10 24 2024-06-28
UTAK LABORATORIES, INC.
 ETOH II_09 24 ETOH II_09 24 2024-06-28
UTAK LABORATORIES, INC.
 ETOH II_08 24 ETOH II_08 242024-06-28
UTAK LABORATORIES, INC.
 ETOH II_07 24 ETOH II_07 242024-06-28
UTAK LABORATORIES, INC.
 ETOH II_06 24 ETOH II_06 242024-06-28
UTAK LABORATORIES, INC.
 MIXED CONTROL LEVEL 2 CONTROL 2 S SH2024-06-20
UTAK LABORATORIES, INC.
 MIXED CONTROL LEVEL 1 CONTROL 1 S SH2024-06-20
UTAK LABORATORIES, INC.
 GABAPENTIN PLUS GABA+ V V2 WB F MSP 2024-06-19
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE DA WB F ODPS2024-06-19
UTAK LABORATORIES, INC.
 LAMOTRIGINE 20 UG/ML LAMO 20 NYP2024-06-13
UTAK LABORATORIES, INC.
 CODEINE GLUCURONIDE PLUS LEVEL 2 COD GLUC+ 2 V2 U PM2024-06-13
UTAK LABORATORIES, INC.
 AMITRIPTYLINE PLUS AMIT+ S WVHS 2024-06-13
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE LEVEL 3 V3 DAU 3 V3 F VMG 2024-06-12
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE LEVEL 2 V3 DAU 2 V3 F VMG2024-06-12
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE LEVEL 1 V3 DAU 1 V3 F VMG 2024-06-12
UTAK LABORATORIES, INC.
 MITOTANE LEVEL 1 MITO 1 SHP MAYO2024-06-11
UTAK LABORATORIES, INC.
 AMPHETAMINES PANEL LEVEL 2 AMPH 2 U F UW2024-06-10
UTAK LABORATORIES, INC.
 AMPHETAMINES PANEL LEVEL 1 AMPH 1 U F UW2024-06-10
UTAK LABORATORIES, INC.
 TCA PANEL LEVEL 3 TCA 3 U WBH2024-06-07
UTAK LABORATORIES, INC.
 FENTANYL KIT FENT KIT U F CLC2024-06-07
UTAK LABORATORIES, INC.
 ARSENIC PLUS LEVEL 3 ARSEN+ 3 WB QD2024-06-07
UTAK LABORATORIES, INC.
 ARSENIC PLUS LEVEL 2 ARSEN+ 2 WB QD2024-06-07
UTAK LABORATORIES, INC.
 ARSENIC PLUS LEVEL 1 ARSEN+ 1 WB QD2024-06-07
UTAK LABORATORIES, INC.
 NIFEDIPINE PLUS NIF+ S F EBS2024-06-05
UTAK LABORATORIES, INC.
 METHAMPHETAMINE CAL SET POS-M220-2-32024-06-03
UTAK LABORATORIES, INC.
 CANNABINOIDS CAL SET POS-M145-2-32024-06-03
UTAK LABORATORIES, INC.
 PENTOBARBITAL LEVEL 2 PENTO 2 V2 S BH 2024-06-03
UTAK LABORATORIES, INC.
 PENTOBARBITAL LEVEL 1 PENTO 1 V2 S BH2024-06-03
UTAK LABORATORIES, INC.
 ANTIFUNGALS LEVEL 2 ANTIF 2 S UPHS2024-05-31
UTAK LABORATORIES, INC.
 ANTIFUNGALS LEVEL 1 ANTIF 1 S UPHS2024-05-31
UTAK LABORATORIES, INC.
 BENZODIAZEPINES MR BENZO MR LC2024-05-29
UTAK LABORATORIES, INC.
 PETH LEVEL 3 PETH 3 K2WB F UM2024-05-28
UTAK LABORATORIES, INC.
 PETH LEVEL 2 PETH 2 K2WB F UM2024-05-28
UTAK LABORATORIES, INC.
 PETH LEVEL 1 PETH 1 K2WB F UM2024-05-28
UTAK LABORATORIES, INC.
 BENZODIAZEPINES HR BENZO HR LC2024-05-28
UTAK LABORATORIES, INC.
 POSITIVE WHOLE BLOOD 44600-WB(F) POS AFT2024-05-28
UTAK LABORATORIES, INC.
 URINE BROAD PANEL HIGH UBP H F DU2024-05-27
UTAK LABORATORIES, INC.
 TESTOSTERONE LEVEL H TESTO H SMX-S F UCH2024-05-24
UTAK LABORATORIES, INC.
 TESTOSTERONE LEVEL G TESTO G SMX-S F UCH2024-05-24
UTAK LABORATORIES, INC.
 TESTOSTERONE LEVEL F TESTO F SMX-S F UCH2024-05-24
UTAK LABORATORIES, INC.
 TESTOSTERONE LEVEL E TESTO E SMX-S F UCH2024-05-24
UTAK LABORATORIES, INC.
 TESTOSTERONE LEVEL D TESTO D SMX-S F UCH2024-05-24
UTAK LABORATORIES, INC.
 TESTOSTERONE LEVEL C TESTO C SMX-S F UCH2024-05-24
UTAK LABORATORIES, INC.
 TESTOSTERONE LEVEL B TESTO B SMX-S F UCH2024-05-24
UTAK LABORATORIES, INC.
 TESTOSTERONE LEVEL A TESTO A SMX-S F UCH2024-05-24
UTAK LABORATORIES, INC.
 PREGNENOLONE PLUS REGN+ SMX S F PC2024-05-24
UTAK LABORATORIES, INC.
 IMMUNOASSAY LEVEL 3 IMMUNO 3 V2 ARUP2024-05-23
UTAK LABORATORIES, INC.
 IMMUNOASSAY LEVEL 2 IMMUNO 2 V2 ARUP2024-05-23
UTAK LABORATORIES, INC.
 IMMUNOASSAY LEVEL 1 IMMUNO 1 V2 ARUP2024-05-23
UTAK LABORATORIES, INC.
 DAU LEVEL 1 DAU 1 F V2 UTMB2024-05-23
UTAK LABORATORIES, INC.
 OPIATES 50 NG/ML OPIA 50 S LHS2024-05-22
UTAK LABORATORIES, INC.
 OPIATES 100 NG/ML OPIA 100 S LHS 2024-05-22
UTAK LABORATORIES, INC.
 BUSULFAN 3500 UG/L BUS 3500 HUP2024-05-21
UTAK LABORATORIES, INC.
 CODEINE GLUCURONIDE PLUS LEVEL 1 COD GLUC+ 1 V2 U PM2024-05-20
UTAK LABORATORIES, INC.
 METHAMPHETAMINE PLUS METH+ P UCD2024-05-17
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE PLUS LEVEL 4 DA+4 WB V3 IMMUN2024-05-16
UTAK LABORATORIES, INC.
 SELENIUM 200 UG/L SELEN 200 S BP2024-05-15
UTAK LABORATORIES, INC.
 SELENIUM 100 UG/L SELEN 100 S BP2024-05-15
UTAK LABORATORIES, INC.
 CERTIFIED DRUG FREE URINE 88121-CDF(F)10 FS 2024-05-14
UTAK LABORATORIES, INC.
 7-AMINOCLONAZEPAM LOW 7-AMINO LOW UPM2024-05-13
UTAK LABORATORIES, INC.
 7-AMINOCLONAZEPAM HIGH 7-AMINO HIGH UPM2024-05-13
UTAK LABORATORIES, INC.
 LAMOTRIGINE PLUS LEVEL 3 LAMO+ 3 V3 S UCH2024-05-10
UTAK LABORATORIES, INC.
 LAMOTRIGINE PLUS LEVEL 2 LAMO+ 2 V3 S UCH2024-05-10
UTAK LABORATORIES, INC.
 LAMOTRIGINE PLUS LEVEL 1 LAMO+ 1 V3 S UCH2024-05-10
UTAK LABORATORIES, INC.
 TESTOSTERONE PLUS LEVEL 2 TESTO+ 2 WB MTL2024-05-09
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
TRICYLIC ANTIDEPRESSANTS Vi2016-10-19
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
TRICYLIC ANTIDEPRESSANTS Li Tx Control2016-10-19
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Whole Blood Lead Controls2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
UTAK Toxicology Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Trace Elements Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Clonazepam Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
UTAK STABBS Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Vancomycin Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Benzodiazepines Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Flurazepam Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Disopyramide Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Pentobarbital Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Caffeine Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Tricyclic Antidepressants Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Maprotiline Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Amoxapine Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
UTAK Toxicology Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Tricyclic Antidepressants Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Hypnotics + Salicylate Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Hypnotics + Acetaminophen Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Barbiturates Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Cardiacs II Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Cardiacs I Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Anticonvulsants Control2007-12-05
UTAK LABORATORIES, INC.
UTAK LABORATORIES TOXICOLOGY CONTROL1991-04-12
UTAK LABORATORIES, INC.
TRACE ELEMENTS SERUM TOXICOLOGY CONTROL1988-10-06
UTAK LABORATORIES, INC.
SERUM VANCOMYCIN TOXICOLOGY CONTROL1986-11-13
UTAK LABORATORIES, INC.
BENZODIAZEPINES TOXICOLOGY CONTROL1986-11-13
UTAK LABORATORIES, INC.
SERUM CLONAZEPAM TOXICOLOGY CONTROL1986-11-05
UTAK LABORATORIES, INC.
UTAK-STABBS TOXICOLOGY CONTROL1986-08-04
UTAK LABORATORIES, INC.
TRICYCLIC ANTIDEPRESSANTS1983-07-28
UTAK LABORATORIES, INC.
FLURAZEPAM TOXICOLOGY CONTROL1983-07-26
UTAK LABORATORIES, INC.
CAFFINE TOXICOLOGY CONTROL1983-07-26
UTAK LABORATORIES, INC.
MAPROTILINE1983-07-26
UTAK LABORATORIES, INC.
AMOXAPINE 8-HYDRO-XYAMOXAPINE1983-07-26
UTAK LABORATORIES, INC.
TRICYCLIC ANTIDEPRESSNATS VI1983-07-19
UTAK LABORATORIES, INC.
DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE1983-07-06
UTAK LABORATORIES, INC.
PENTOBARBITAL TOXICOLOGY CONTROL1983-07-06
UTAK LABORATORIES, INC.
TOXICOLOGY CONTROL1981-02-04
UTAK LABORATORIES, INC.
TRICYCLIC ANTIDEPRESSANTS I TX CONTROL1980-05-02
UTAK LABORATORIES, INC.
TRICYCLIC ANTIDEPRESSANT II TX CONTROL1980-04-29
UTAK LABORATORIES, INC.
HYPNOTICS PLUS SALICYLATE TX CONTROL1980-04-29
UTAK LABORATORIES, INC.
HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL1980-04-29
UTAK LABORATORIES, INC.
BARBITURATES TOXICOLOGY CONTROL1980-04-29
UTAK LABORATORIES, INC.
CARDIACS II TOXICOLOGY CONTROL1980-04-29
UTAK LABORATORIES, INC.
CARDIACS I TOXICOLOGY CONTROL1980-04-29
UTAK LABORATORIES, INC.
ANTICONVULSANTS TOXICOLOGY CONTROL1980-04-29

Related Finance Registrations
NCAGE Code1GED8UTAK LABORATORIES INC
NCAGE Code5Z914UTAK LABORATORIES INC
CAGE Code1GED8UTAK LABORATORIES INC
CAGE Code5Z914UTAK LABORATORIES INC
S.A.M. Registration1GED8 [92519016]UTAK LABORATORIES INC
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